Modified release composition comprising a short-acting hypnotic for treatment of sleep disorders

Abstract

A pharmaceutical composition comprising a first component comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof; a second component comprising at least one particle, wherein the at least one particle comprises a core and at least one coating over the core, the core comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof, and the at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 5.5, and optionally a third component comprising at least one particle, wherein the at least one particle comprises a core and at least one coating over the core, the core comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof, and the at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 6.0. Methods of treating sleep disorders, prolonging sleep, and inducing sleep using these compositions are also disclosed.

1 . A pharmaceutical composition comprising: 
 a) a first component comprising zaleplon or a pharmaceutically acceptable salt thereof; and    b) a second component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising zaleplon or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 5.5.    
     
     
         2 . A pharmaceutical composition according to  claim 1 , wherein said at least one polymer is soluble at a pH greater than or equal to about 6.0.  
     
     
         3 . A pharmaceutical composition according to  claim 1 , wherein said at least one polymer is soluble at a pH greater than or equal to about 7.0.  
     
     
         4 . A pharmaceutical composition according to  claim 1 , wherein said zaleplon is present in a total amount chosen from 10, 15, 20, and 25 mg.  
     
     
         5 . A pharmaceutical composition according to  claim 1 , wherein the amount of zaleplon present in each component ranges from about 30% to about 70%.  
     
     
         6 . A pharmaceutical composition comprising: 
 a) a first component comprising zaleplon or a pharmaceutically acceptable salt thereof;    b) a second component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising zaleplon or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 5.5; and    c) a third component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising zaleplon or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 6.0.    
     
     
         7 . A pharmaceutical composition according to  claim 6 , wherein the amount of zaleplon present in each component ranges from about 15% to about 50%.  
     
     
         8 . A pharmaceutical composition comprising: 
 a) a first component comprising zaleplon or a pharmaceutically acceptable salt thereof;    b) a second component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising zaleplon or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 5.5; and    c) a third component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising zaleplon or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 7.0.    
     
     
         9 . A pharmaceutical composition according to  claim 8 , wherein the amount of zaleplon present in each component ranges from about 15% to about 50%.  
     
     
         10 . A pharmaceutical composition comprising: 
 a) a first component comprising zaleplon or a pharmaceutically acceptable salt thereof;    b) a second component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising zaleplon or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 6.0; and    c) a third component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising zaleplon or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 7.0.    
     
     
         11 . A pharmaceutical composition according to  claim 10 , wherein the amount of zaleplon present in each component ranges from about 15% to about 50%.  
     
     
         12 . A pharmaceutical composition comprising: 
 a) a first component comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof; and    b) a second component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 5.5.    
     
     
         13 . A pharmaceutical composition according to  claim 12 , wherein said short-acting hypnotic is chosen from zaleplon, zopiclone, triazolam, temazepam, brotizolam, alimemazine, or zolpidem, and combinations thereof.  
     
     
         14 . A pharmaceutical composition according to  claim 12 , wherein said at least one polymer is soluble at a pH greater than or equal to about 6.0.  
     
     
         15 . A pharmaceutical composition according to  claim 12 , wherein said at least one polymer is soluble at a pH greater than or equal to about 7.0.  
     
     
         16 . A pharmaceutical composition comprising: 
 a) a first component comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof;    b) a second component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 5.5; and    c) a third component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 6.0.    
     
     
         17 . A pharmaceutical composition according to  claim 16 , wherein said short-acting hypnotic is chosen from zaleplon, zopiclone, triazolam, temazepam, brotizolam, alimemazine, or zolpidem, and combinations thereof.  
     
     
         18 . A pharmaceutical composition comprising: 
 a) a first component comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof;    b) a second component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 5.5; and    c) a third component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 7.0.    
     
     
         19 . A pharmaceutical composition according to  claim 18 , wherein said short-acting hypnotic is chosen from zaleplon, zopiclone, triazolam, temazepam, brotizolam, alimemazine, or zolpidem, and combinations thereof.  
     
     
         20 . A pharmaceutical composition comprising: 
 a) a first component comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof;    b) a second component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 6.0; and    c) a third component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising a short-acting hypnotic or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 7.0.    
     
     
         21 . A pharmaceutical composition according to  claim 20 , wherein said short-acting hypnotic is chosen from zaleplon, zopiclone, triazolam, temazepam, brotizolam, alimemazine, or zolpidem, and combinations thereof.  
     
     
         22 . A pharmaceutical composition according  claim 12 , wherein said short-acting hypnotic is present in a total amount chosen from 1, 5, 10, 15, 20, and 25 mg.  
     
     
         23 . A method for treating sleep disorders comprising administering to a patient in need of such treatment an effective amount of a pharmaceutical composition comprising: 
 a) a first component comprising zaleplon or a pharmaceutically acceptable salt thereof; and    b) a second component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising zaleplon or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 5.5.    
     
     
         24 . The method according to  claim 23 , wherein the at least one pharmaceutically acceptable polymer is soluble at a pH greater than or equal to about 6.0.  
     
     
         25 . The method according to  claim 23 , wherein the at least one pharmaceutically acceptable polymer is soluble at a pH greater than or equal to about 7.0.  
     
     
         26 . A method of treating sleep disorders according to  claim 23 , wherein said sleep disorders are acute.  
     
     
         27 . A method of treating sleep disorders according to  claim 23 , wherein said sleep disorders are chronic.  
     
     
         28 . A method for treating sleep disorders comprising administering to a patient in need of such treatment an effective amount of a pharmaceutical composition comprising: 
 a) a first component comprising zaleplon or a pharmaceutically acceptable salt thereof;    b) a second component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising zaleplon or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 5.5; and    c) a third component comprising at least one particle, wherein said at least one particle comprises a core and at least one coating over said core, said core comprising zaleplon or a pharmaceutically acceptable salt thereof, and said at least one coating comprising at least one pharmaceutically acceptable polymer that is soluble at a pH greater than or equal to about 6.0.    
     
     
         29 . A method for treating sleep disorders according to  claim 28 , wherein said at least one pharmaceutically acceptable polymer on said second component is soluble at a pH greater than or equal to about 6.0, and said at least one pharmaceutically acceptable polymer on said third component is soluble at a pH greater than or equal to about 7.0.  
     
     
         30 . A method of treating sleep disorders according to  claim 28 , wherein said sleep disorders are acute.  
     
     
         31 . A method of treating sleep disorders according to  claim 28 , wherein said sleep disorders are chronic.  
     
     
         32 . A method of inducing sleep in a patient, comprising administering to said patient an effective sleep-inducing amount of a composition according to  claim 1 .  
     
     
         33 . A method of prolonging sleep in a patient, comprising administering to said patient an effective sleep-prolonging amount of a composition according to  claim 1 .  
     
     
         34 . A method of treating sleep disorders according to  claim 23 , wherein said composition is in a form whereby it can be sprinkled on said patient's food and ingested by said patient.  
     
     
         35 . A method of inducing sleep in a patient, comprising administering to said patient an effective sleep-inducing amount of a composition according to  claim 12 .  
     
     
         36 . A method of prolonging sleep in a patient, comprising administering to said patient an effective sleep-prolonging amount of a composition according to  claim 12 .  
     
     
         37 . The method of  claim 23 , wherein said patient does not experience a hangover effect.